Nasrin Nabavi
- Role
- Quality Assurance at Edgewell Personal Care
- Location
- Dover, DE, US
- LinkedIn followers
- 500 followers
About Nasrin Nabavi
9 years’ experience in Quality Control/Assurance/Regulatory Affairs and Managing in…
Experience
Quality Assurance
May 2022 — Present
Ensured compliance with all Health Canada, FDA and GMP, Environmental Policy and EH & S requirements; maintain foreign licenses • Support the correct implementation of QMS to ensure compliance with all regulatory requirements with a focus on ISO 13485/22716/16949, MDSAP, 21CFR 210/211, CMDR SOR/98-282, FDA, CE and other regulatory requirements specified by the scope of the Quality Manual applicable to Company (Managing the process for the implementation and documentation required for ISO 13485, ISO 16949 and ISO 14001; Creating, maintaining documentation, protocols, and coordinating test results for FDA approval • Ensure quality systems are implemented/followed (e.g. temperature monitoring, calibration program, document control, product testing, specifications, Evaluation and validation, supplier quality, investigations, CC procedures, etc.) • Pertain to Internal Audits, Corrective and Preventive Action (CAPA), Customer Complaints, Non-Conformance Reports (NCR), Deviations Analysis, Change Control, Consumer Complaint Handling, Document Control, and Supplier Quality, Supplier Corrective Actions (SCAR) and Ensure the effective and timely closure and notification of requests for investigations; and ensuring compliance with requirements • Maintain of audit files; Developed and established quality assurance policies, processes, procedures, and controls ensuring the efficiency and ongoing improvement of the quality system elements • Maintain/Observe Quality Policy, Quality Manuel, and Quality System Procedure requirements, department training matrix/files, raw data, regulations, SOP/WIs, Device Master Records, product/material specifications, and packaging assembly specs for all departments • Communicate/interact with cross functional groups and Ensure quality agreements/contracts are established and in place with suppliers, contract manufacturers, and service providers • Ensure Quality tools (RCA, Risk Analysis, DOE, SPC and MSA, etc.) are used to solve complex problems
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